Devices and methods facilitating sleeve gastrectomy and other procedures

ABSTRACT

A device for use in bariatric surgery includes a flexible hollow tube extending from a proximal end to a distal end and defines a channel therebetween. A series of openings is defined in a distal portion of the tube allowing for fixation of tissue using suction. A flexible member has an initial position disposed alongside the tube and is deployable to a subsequent position in which the flexible member engages a greater curvature of a stomach. The flexible member is configured to be deployable to automatically assume a shape of a greater curvature of a stomach. The flexible member includes a bulging region and a tapering region when deployed. The flexible member is releasably attached to the distal end of the tube.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 16/223,586, filed on Dec. 18, 2018, which is a continuation ofU.S. patent application Ser. No. 14/491,660, filed Sep. 19, 2014, nowU.S. Pat. No. 10,159,425, which claims the benefit of and priority toU.S. Provisional Application Ser. No. 61/901,870, filed Nov. 8, 2013,the entire contents of each of which are incorporated herein byreference.

BACKGROUND Technical Field

The present disclosure relates generally to gastrointestinal surgery,such as, for example, sleeve gastrectomy, and to devices and methodsthat facilitate performing resection of gastric and other tissue.

Background of Related Art

Obesity is reaching epidemic proportions in many regions of the world,particularly in the United States. In order to treat obesity, varioussurgical procedures have been developed including, for example, gastricbypass, adjustable gastric banding, and sleeve gastrectomy. The goal ineach of these procedures is to reduce the stomach capacity to restrictthe amount of food that the patient can eat. The reduced stomachcapacity, in turn, results in a feeling of fullness for the patientafter ingesting a relatively smaller amount of food. Thus, the patientcan achieve significant weight loss.

Sleeve gastrectomy involves transecting a stomach, e.g., using astapling device or other suitable device, to reduce a stomach volume.Sleeve gastrectomy procedures are often aided by the use of a bougie,which serves as a guide or template for transecting the stomach to theappropriate configuration while inhibiting inadvertent transection ofstomach or esophageal tissue. Once the stomach has been appropriatelytransected, the bougie is removed and a leak test is performed todetermine whether there are any areas of extravasation.

There is a need for a device and/or method of positioning andstabilizing a stomach, or other hollow organ, to avoid shifting of thesides of the organ with respect to one another during transection,stapling, etc., in a surgical procedure. There is a need for a simpler,more convenient way to perform a leak test, visualize the transectedtissue, etc.

SUMMARY

In an aspect of the present disclosure, .a medical device comprises: aflexible hollow tube extending from a proximal end to a distal end anddefining a channel therebetween, a series of openings being defined in adistal portion of the tube allowing for fixation of tissue usingsuction; a flexible member having an initial position disposed alongsidethe tube and being deployable to a subsequent position in which theflexible member engages a greater curvature of a stomach, theapplication of suction placing the tube along a lesser curvature of astomach, fixing anterior and posterior walls of a stomach, andpreventing their movement, the tube being visible under stomach tissue,the flexible member being configured to be deployable to automaticallyassume a shape of a greater curvature of a stomach, the flexible memberincluding a bulging region and a tapering region when deployed, whereinthe flexible member includes at least one illumination device.

The medical device can include a tube that has a proximal end that isopen. The medical device preferably has a tube with a distal portionthat is tapered. The medical device can further comprise a release wirefor separating the flexible member from the tube.

A distal end of the flexible member can includes a balloon. The balloonis desirably shaped to position the flexible member in the stomach.

In certain embodiments, the flexible member includes a hinge adjacent adistal end of the flexible member. The flexible member can be selectedfrom the group consisting of a rod and a tube. The flexible member isdesirably made of a flexible resilient material.

The medical device, in certain embodiments, has a flexible member with adistal end attached to the distal end of the tube, and a proximal endmanipulable from outside a patient's body.

In certain embodiments, the device includes a coupling device that holdsthe flexible member to the tube. The coupling device can slidably attachan intermediate portion of the flexible member to an intermediateportion of the tube.

The flexible member can be deployable to align a stomach by evening outanterior and posterior walls of a stomach and by pushing the tube andthe openings in the tube towards a lesser curvature of a stomach.

In certain preferred embodiments, the proximal end of the tube isconfigured for connection to a suction source.

The tube has a cross-sectional shape that may be selected from the groupconsisting of triangular, diamond, elliptical, and tapered.

The tube may include at least one illumination device. At least one ofthe tube or the flexible member may include a vision device. Theflexible member can have multiple attachments to the tube, theattachments being distributed down a length of the tube. The flexiblemember can include a distal end releasably attached to the distal end ofthe tube.

In certain preferred embodiments, the flexible member has a plurality ofillumination devices distributed across its length.

In an aspect of the present disclosure, a medical device comprises aflexible hollow tube extending from a proximal end to a distal end anddefining a channel therebetween. A series of openings is defined in adistal end portion of the tube allowing for fixation of tissue usingsuction. The medical device further includes a flexible member having aninitial position disposed alongside the tube and deployable to asubsequent position in which the tube engages a greater curvature of astomach. Application of suction places the tube along a lesser curvatureof a stomach, fixing anterior and posterior walls of the stomach, andpreventing their movement. The tube is visible under stomach tissue. Theflexible member is configured to be deployable to automatically assumethe shape of a greater curvature of the stomach. The flexible memberincludes a bulging region and a tapering region. The flexible member isreleasably attached to the distal end of the tube.

In embodiments, the proximal end of the hollow tube may be open. Thedistal end of the tube may be tapered. The medical device can include arelease wire for separating the flexible member from the tube. Themedical device may further include a balloon at the distal end of theflexible member. The balloon may be shaped to position the flexiblemember in the stomach. The flexible member may include a hinge adjacenta distal end of the flexible member.

The flexible member may be a rod or tube of a flexible resilientmaterial having a distal end attached to the distal end of the tube. Theflexible member may include a proximal end manipulable from outside apatient's body. The tube may be made of silicone.

In aspects of the present disclosure, the medical device may include acoupling device that holds the flexible member to the tube. The couplingdevice can slidably attach an intermediate portion of the flexiblemember to an intermediate portion of the tube. The flexible member ormovable element can be deployable to align the stomach by evening outthe anterior and posterior walls of the stomach and by pushing the tubeand a perforated area of the tube towards the lesser curvature of thestomach. Suction can be applied at the proximal end of the tube. Air orcolored fluid can be instilled into a proximal end of the tube toperform a leak test.

The tube can have a cross-sectional shape selected from the groupconsisting of triangular, diamond, elliptical, and tapered. The tube,member, or both, can include at least one illumination device. The atleast one illumination device can be an LED. The tube, member, or both,can include a vision device. The vision device can be a camera or ascope.

In another aspect of the present disclosure, a medical device comprisesa flexible hollow tube extending from a proximal end to a distal end anddefines a channel therebetween. A series of openings is defined in adistal end portion of the tube allowing for fixation of tissue usingsuction. The medical device further includes a flexible member having aninitial position disposed alongside the tube and deployable to asubsequent position in which the flexible member engages a greatercurvature of a stomach. The application of suction places the tube alonga lesser curvature of the stomach, fixing anterior and posterior wallsof the stomach, and preventing their movement. The tube is visible understomach tissue. The flexible member is configured to be deployable toautomatically assume the shape of the greater curvature. The flexiblemember includes a bulging region and a tapering region. The flexiblemember has multiple attachments to the tube distributed down a length ofthe tube. The flexible member includes a distal end releasably attachedto the distal end of the tube.

In embodiments, the proximal end of the hollow tube can be open. Thedistal end of the tube can be tapered. The medical device may include arelease wire for separating the member from the tube at the attachments.The medical device can further include a balloon at the distal end ofthe member. The balloon may be shaped in a manner so as to position theflexible member in the stomach.

The flexible member may be a rod or tube of a flexible resilientmaterial having a distal end attached to the distal end of the tube, anda proximal end manipulable from outside a patient's body. The tube canbe made of silicone.

The medical device may include a coupling device that holds anintermediate portion of the flexible member to the tube. The couplingdevice can slidably attach the intermediate portion of the member to anintermediate portion of the tube. The flexible member can be deployableto align the stomach by evening out the anterior and posterior walls ofthe stomach and by pushing the tube and a perforated area of the tubetowards the lesser curvature of the stomach. Suction can be applied atthe proximal end of the tube. Air or colored fluid can be instilled intoa proximal end of the tube to perform a leak test.

The tube can have a cross-sectional shape selected from the groupconsisting of triangular, diamond, elliptical, and tapered. The tube,member, or both, can include at least one illumination device. The atleast one illumination device can be an LED. The tube, member, or both,can include a vision device. The vision device can be a camera or ascope.

In a further aspect of the present disclosure, a medical devicecomprises a flexible hollow tube extending from a proximal end to adistal end and defines a channel extending therebetween. A series ofopenings is defined in a distal end portion of the tube allowing forfixation of tissue using suction. The medical device further includes aflexible member having an initial position disposed alongside the tubeand deployable to a subsequent position in which the flexible memberengages a greater curvature of a stomach. Application of suction placesthe tube along a lesser curvature of the stomach, fixing anterior andposterior walls of the stomach, and preventing their movement. The tubeis visible under stomach tissue. The flexible member is configured to bedeployable to automatically assume a shape of a greater curvature of thestomach. The flexible member includes a bulging region and a taperingregion. The medical device further includes an expandable elementdisposed alongside the distal end of the tube.

In embodiments, the expandable element is an inflatable balloon. Theballoon may be inflatable to enlarge an effective diameter of themedical device. In some embodiments, the expandable element may be alever pivotably attached to the distal end of the tube. The lever may bepivotable in two directions.

The proximal end of the hollow tube may be open. The distal end of thetube may be tapered. The medical device may include a release wire forseparating the member from the tube. The expandable element may bevisible through stomach tissue. The expandable element may be used toindicate a location for an initial stapling and/or cutting operation.

The flexible member may be a rod or tube of a flexible resilientmaterial having a distal end attached to the distal end of the tube, anda proximal end manipulable from outside a patient's body. The tube maybe made of silicone.

In embodiments, the medical device may include a coupling device thatholds the flexible member to the tube. The coupling device can slidablyattach an intermediate portion of the member to an intermediate portionof the tube. The flexible member can be deployable to align the stomachby evening out the anterior and posterior walls of the stomach and bypushing the tube and a perforated area of the tube towards the lessercurvature of the stomach. Suction can be applied at the proximal end ofthe tube. Air or colored fluid can be instilled into a proximal end ofthe tube to perform a leak test.

The tube can have a cross-sectional shape selected from the groupconsisting of triangular, diamond, elliptical, and tapered. The tube,member, or both, can include at least one illumination device. The atleast one illumination device can be an LED. The tube, member, or both,can include a vision device. The vision device can be a camera or ascope.

In another aspect of the present disclosure, a medical device comprisesa flexible hollow tube extending from a proximal end to a distal end anddefines a channel therebetween. At least one opening is defined in thedistal end of the tube. The medical device further includes a flexiblemember having an initial position disposed alongside the tube and isdeployable to a subsequent position. The flexible member is configuredto be deployable to automatically assume a shape of a greater curvatureof a stomach. The medical device further includes a reusable portionhaving a first tank of fluid, a second tank for receiving material, anda third tank communicating with atmospheric pressure. The reusableportion has a first valve, a second valve, and a third valve. The firstvalve and second valve each have a first position, a second position,and a third position. The channel is delivered with pressurized fluidwhen the first valve and the second valve are moved to the firstposition.

In embodiments, the second position of the first valve and the secondvalve is a closed position. The third valve may have a position in whicha vacuum is provided to the channel. The device can further comprise asafety feature preventing the third valve from moving to an openposition unless the first valve and the second valve are moved to thesecond position. The second position of the first valve and the secondvalve may be a closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedherein with reference to the drawings, wherein:

FIG. 1 is a schematic illustration showing a medical device inaccordance with an embodiment of the present disclosure;

FIG. 2 is a perspective view of an embodiment of a medical deviceaccording to the present disclosure, inserted into a stomach;

FIG. 3 is a schematic, cutaway view, in part phantom, of a medicaldevice according to another embodiment of the present disclosure;

FIG. 4 is a perspective view of the medical device shown in FIG. 3,inserted into a patient's stomach;

FIG. 5 is a cross-sectional view of a tube of a medical device inaccordance with further embodiments of the present disclosure;

FIG. 6 is a perspective view of a medical device according to anotherembodiment of the present disclosure, inserted into a stomach;

FIG. 7 is a schematic view illustrating a medical device in accordancewith another embodiment of the present disclosure;

FIG. 8 is a cutaway view of detail A shown in FIG. 7;

FIG. 9 is a perspective view of the medical device shown in FIG. 7;

FIG. 10 is a perspective view of a medical device according to anotherembodiment of the present disclosure, inserted into a stomach;

FIG. 11 is a schematic view of a system for controlling a medical deviceaccording to another embodiment of the present disclosure;

FIG. 12 is a perspective view, in part phantom, of a medical deviceaccording to another embodiment of the present disclosure, with themember in a pre-deployed position;

FIG. 13 is a perspective view, in part phantom, of the medical deviceshown in FIG. 12, with the member in a retracted position;

FIG. 14 is a perspective view of a medical device in accordance withanother embodiment of the present disclosure, with the member and scopeshown in a retracted position;

FIG. 15 is a perspective view of a medical device in accordance withanother embodiment of the present disclosure;

FIG. 15A is a cross-sectional view taken across line 15A-15A in FIG. 15;

FIGS. 16A through 16E are cross-sectional views of tubes of a medicaldevice according to embodiments of the present disclosure;

FIG. 17 is a cross-sectional view of a tube of a medical deviceaccording to embodiments of the present disclosure;

FIG. 18 is a cross-sectional view of a tube of a medical deviceaccording to embodiments of the present disclosure;

FIG. 19A is a schematic view of a tube of a medical device according toanother embodiment of the present disclosure;

FIG. 19B is a schematic view of a tube of a medical device according toa further embodiment of the present disclosure;

FIGS. 20A through 20C are schematic views of tubes of a medical deviceaccording to embodiments of the present disclosure; and

FIG. 21 is a schematic view of a tube of a medical device according toembodiments of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the present disclosure are detailed below with referenceto the drawings in which like reference numerals designate identical orcorresponding elements in each of the several views. Throughout thisdescription, the term “proximal” will refer to the portion of themedical device or component thereof that is closest to the mouth of thepatient, and the term “distal” will refer to the portion of the medicaldevice or component that is farther along the digestive tract. The termproximal has also been used to refer to the portion of the medicaldevice or component that is generally closest to the user and the term“distal” has been used to refer to the portion of the medical device orcomponent thereof that is generally farthest from the user.

Turning now to FIGS. 1, 2, and 7-9, a surgical system 2 is provided thatincludes a medical device designated as 10 in accordance with anembodiment of the present disclosure. The medical device 10 isconfigured for use in resection of gastrointestinal tissue. As anexample, the medical device 10 can be used in a sleeve gastrectomyprocedure.

The medical device 10 includes an elongated tube 20 and an elongatedmember 40 coupled to the tube 20. The materials for the tube 20 and themember 40 are generally polymeric materials appropriate for surgicalapplications, such as the materials used to make a bougie or catheter.The tube 20 is hollow, whereas the member 40 can be hollow or solid.Tube 20 is formed from flexible materials such as silicone and rubber,although other suitable flexible materials are also contemplated. Tube20 has a distal portion 22 and a proximal portion 24 and defines atleast one lumen 26 extending therethrough. A plurality of perforationsor openings 28 are defined through an outer wall of distal portion 22 oftube 20. Openings 28 enable fluid communication through the outer wallof tube 20 between lumen 26 and the exterior of tube 20.

Tube 20 further includes a distal end cap 30 disposed at distal portion22, or is otherwise closed. The distal portion 22 of the tube 20 can beclosed in any appropriate manner. Distal end cap 30 may define a roundedtapered configuration, blunt conical configuration, or any othersuitable configuration that facilitates atraumatic insertion into apatient's stomach. Distal end cap 30 is affixed to the distal portion 22of tube 20 to seal off lumen 26 at the distal portion 22 of tube 20. Thetube 20 can have a diameter between about 32-42 French.

Tube 20 has an open proximal portion 24 configured to connect to asuction source “S” and a fluid source “F” (see FIG. 1). Suction source“S” is operable to provide suction within lumen 26 for suctioningfluids, stomach contents, etc., through apertures or openings 28 andinto lumen 26 for removal and/or for suctioning stomach tissue intocontact with tube 20. One or more control members 32, e.g., a valve, maybe disposed between tube 20 and the suction source “S” to control thesuction force being applied. It is contemplated that controls mayalternatively or additionally be provided on a user interface (notshown) of the suction source “S.” The medical device 10 has at least ashut off valve 60 at a vacuum port 61, and another shut off valve 62 ata fluid/air supply port 63, at proximal portion 24 of tube 20 (FIG. 7).Fluid source “F” is configured to pump fluid, e.g., water or air, intolumen 26 of tube member 20 and out through apertures 28 into thestomach. Similar to suction source “S,” the fluid source “F” may includeone or more control members 34 (FIG. 1) to control the flow rate and/orpressure of fluid being pumped through lumen 26 of tube 20, and thevacuum pressure. In some embodiments, the controls may alternatively oradditionally be provided on a user interface (not shown) of the fluidsource “F.”

Continuing with reference to FIG.1, member 40 is formed from asemi-rigid, resiliently flexible material, e.g., a suitable elastomer,and defines a length greater than the length of tube 20 such that member40 can be accessed outside the patient and/or remotely of the surgicalsite. Member 40 has a distal portion 42 having a distal end 43 and aproximal portion 44. Distal end 43 of member 40 is integrally, i.e.,monolithically, formed with or otherwise affixed to distal portion 22 ordistal end cap 30 of tube 20.

A coupling 50, e.g., a ring, sleeve, hook, latch, etc., is affixed totube 20. Coupling 50 slidably receives the member 40 therethrough tomovably or slidably couple member 40 to tube 20 in a position betweenthe distal and proximal ends 22, 24 of tube 20. As a result of theabove-configuration, a portion of member 40 is movable or slidablethrough the coupling 50 and relative to tube 20 between an initialposition in which member 40 is disposed alongside tube 20 (see FIG. 1)and deployable to a subsequent position in which member 40 engages agreater curvature of a stomach, as shown, for example, in FIG. 9. In theinitial, contracted position of member 40, distal portion 42 of member40 extends along and abuts the outer surface of the tube 20. In thesubsequent, deployed position, the distal portion 42 of member 40 isbowed outwardly from tube member 20, as shown in FIG. 9.

In the deployed position, the member 40 automatically assumes the shapeof the greater curvature of the stomach, forming a bulging region 42 aand a tapering region 42 b due to the pliability of member 40. Themember 40 defines a configuration that generally complements thecurvature of the greater curvature portion “C2” of the stomach “ST” (seeFIG. 9). Preferably, the flexibility and resilience and dimensioning ofthe member 40 is such that member 40 automatically forms a half-heartshape, with a large, bowed curvature adjacent the proximal portion 44.Such a shape complements the greater curvature of the stomach. Thesefeatures can be adapted to applications in other hollow organs as well.The member 40 should be strong enough to stretch out the stomach, andreposition the anterior and posterior walls of the stomach.

Proximal portion 44 of member 40 may be grasped and manipulated to move,translate, or slide relative to tube 20 to transition member 40 betweenthe contracted and deployed positions. The member 40 may have anactuator or handle to be grasped and manipulated. As mentioned above,member 40 is dimensioned such that proximal portion 44 is accessiblefrom outside the patient, thus readily enabling manipulation thereof,and allowing proximal portion 44 of member 40 to be moved, translated,or slid downwardly with respect to the tube 20. More specifically,translating member 40 in a distal direction relative to tube member 20urges member 40 in a distal direction through coupling 50 such thatdistal portion 42 of member 40 is bowed outwardly relative to tube 20towards the deployed position. Translating member 40 in a proximaldirection relative to tube 20 pulls member 40 proximally throughcoupling 50 such that the distal portion 42 of member 40 is pulledinwardly relative to tube 20 to the contracted position. As analternative to manually manipulating rod member 40, an actuator oractuation assembly (not shown) may be coupled to the proximal ends 24,44 of tube 20 and member 40 to enable selective translation of member 40relative to tube 20.

In any of the embodiments disclosed herein, the distal end 43 of member40 can include a loop or hook 46 and a hinge 45, as shown in FIG. 7. Arelease wire or member 70 extends distally toward the distal end 43 andis accessible at the proximal ends 44, 24 of the member 40 and tube 20.The release wire 70 has a distal end 72 that extends through the loop46, maintaining the connection between the member 40 and the tube 20.The proximal end 44 of the member 40 can have an actuator or handle tofacilitate manipulation thereof. The hinge 45 allows the member 40 to bepositioned alongside the tube 20. Translating the release wire 70 in aproximal direction frees the member 40 from the tube 20, ensuring thatthe member 40 can be detached from the tube 20, as shown in FIG. 2,before resection and/or stapling of tissue occurs. In this way, the userof the medical device 10 can avoid stapling the member 40 and leavingpart of it within the stomach tissue. Alternatively, the hinge 45 can bea frangible connection that can be broken to allow the member 40 to beremoved or detached.

In any of the embodiments disclosed herein, a balloon 80 can be providedas part of the medical device 10, at a distal end of the member 40 (seeFIGS. 2, 7-9). The balloon or other expandable element 80 can beinflated using the fluid/air supply mentioned above, or the member 40can have a separate passageway for this purpose. The balloon 80 can beshaped to complement a portion of the stomach and is disposed on themember 40 so that in the stomach it will be positioned at a specificdistance (typically 6 cm) from the pyloric sphincter. This helps tostart the transection at the preferred location, which is at a distanceof about 6 cm from the sphincter. In addition, the balloon 80 indicatesthe location of the initial placement of a stapling and cutting device,as discussed further below.

Alternatively, to the balloon 80, an expandable element or a lever 84may be attached to the member 40 at the distal end 43 of the member 40,as shown in FIG. 10. The lever 84 is pivotable in two directions towardand away from the lesser curvature of the stomach. The lever 84 has aninitial position substantially parallel with the tube 20 or member 40,and a deployed, perpendicular or transverse position with respect to themember 40. The lever 84 is actuated by pulling a trigger, pushing abutton, or releasing potential energy.

Referring to FIGS. 7-9, the use of medical device 10 during the courseof a sleeve gastrectomy procedure is described. However, it is alsoenvisioned that medical device 10 be capable of use in other similarsurgical procedures, within hollow organs other than the stomach, etc.Initially, with member 40 disposed in the contracted condition, and theballoon or expandable element 80 in an initial, collapsed or deflatedposition, medical device 10, led by distal end cap 30, is insertedthrough the patient's mouth, esophagus, and into the patient's stomach“ST.” At least distal portion 22 of tube 20, coupling 50, and distalportion 42 of member 40 are disposed within the patient's stomach “ST.”Once this position has been achieved, proximal portion 44 of member 40is translated distally relative to tube 20 such that distal portion 42of member 40 bows outwardly relative to tube 20 towards the deployedposition (see FIG. 9). As distal portion 42 of member 40 bows outwardlytowards the deployed position, tube 20 is urged towards and intocomplementary mating relation with the lesser curvature portion “C1” ofthe stomach “ST,” while distal portion 42 of member 40 is urged towardsand into complementary mating relation with the greater curvatureportion “C2” of the stomach “ST”, engaging and flattening the stomach.As such, the orientation of medical device 10 with tube 20 extendingalong the lesser curvature portion “C1” of the stomach “ST” between theesophageal sphincter “E” and the pyloric sphincter “P” can be readilyachieved. As a result of this configuration of medical device 10 in thedeployed position, the above-described orientation of device 10 withinthe stomach “ST” is maintained despite spasms, folding, spiraling,and/or shifting of the stomach “ST.” Further, the configuration ofmedical device 10 allows for proper positioning within the stomach “ST”without the assistance of a viewing instrument, e.g., an endoscope (seeFIG. 6). At this point, the balloon 80 can be inflated, using thefluid/air source, or other source of fluid pressure, to help positionthe distal portion 22 of tube 20 in or near the pylorus.

Once the proper orientation of tube 20 of medical device 10 has beenachieved, suction/vacuum source “S” may be activated to apply suctionwithin lumen 26 for suctioning any remaining contents within the stomach“ST” into lumen 26 of tube 20 through apertures 28. Application ofsuction within lumen 26 also suctions the lesser curvature portion “C1”of the stomach “ST” to the outer periphery of tube 20, to ensure andmaintain the complementary mating relation of tube member 20 with thelesser curvature portion “C1” of the stomach “ST.” Control member 32 maybe manipulated or otherwise controlled to apply sufficient suction tomaintain the relative position of tube 20 without damaging surroundingtissue.

Due to the suction applied to the stomach tissue “ST,” the tube 20 andthe balloon 80 are visible from the exterior of the stomach. The user ofthe medical device 10 places a surgical stapling and cutting deviceadjacent the balloon 80, while avoiding the balloon 80, and fires thestapling and cutting device (see FIG. 9) to make the initialtransection. The balloon 80 can then be deflated or otherwise collapsed.Alternatively, lever 84 is used to position the distal portion 22 of thetube 20 with respect to the pyloric sphincter, and/or indicate theinitial location of the stapling and cutting device.

The proximal portion 44 of member 40 is then translated proximallyrelative to tube 20 such the distal portion 42 of member 40 is pulledinwardly relative to tube 20 back to the contracted position. The member40 is then detached from the tube 40, by pulling on the member 40 tobreak the frangible connection between distal end 43 of member 40 anddistal portion 22 of tube 20, or by moving the release wire 70 to detachthe distal end 43 of the member 40 from the distal portion 22 of tube20. The member 40 is then completely removed from the medical device 10.The shape of the tube 20 is then used as a guide for further cutting andstapling. In this way, a tubular section of stomach tissue is defined.

Transection of the stomach “ST” adjacent tube member 20 on a side oftube member 20 opposite to the lesser curvature portion “C1” of thestomach “ST” may be effected in any suitable fashion, e.g., using astapling device or other suitable device. Transection in this mannerreforms the stomach “ST” to a tubular-shaped configuration (or sleeve)that is slightly larger than the outer dimension of tube 20 and extendsbetween the esophageal sphincter “E” and the pyloric sphincter “P.” Thesuction is maintained while the stomach tissue is transected andstapled. As can be appreciated, the diameter of tube 20 may be selectedin accordance with a desired diameter of the tubular-shape reformedstomach. The remaining stomach tissue is removed from the patient.

Upon completion of the stomach transection, the applied suction isremoved and a leak test is performed. The leak test is performed byactivating the fluid source “F” to pump fluid through lumen 26 of tube20 and into the stomach via apertures 28. The fluid may be air, coloredwater, or other suitable gaseous or liquid leak test agent. The fluid ispumped into the stomach “ST,” e.g., via controlling control member 34,to achieve a pressure within the stomach “ST” sufficient to test thetransected stomach tissue for extravasation. If extravasation (leakage)is detected, the leak is repaired prior to completing the procedure, bysuturing or any other appropriate method. The leak test is repeatedafter repairing the portion or portions of transected tissue whereextravasation is detected, until no further extravasation is detected.Ultimately, medical device 10 is withdrawn from the patient's stomach“ST.” A scope can be provided with the medical device 10, and the tube20 may have a separate passageway for the scope or other devices, asshown in FIG. 5. Alternatively, the user of the medical device 10 maypass a scope through the singular passageway as needed.

In any of the embodiments disclosed herein, the tube 20 can be made of aclear polymer and a scope or camera may be provided. In any of theembodiments disclosed herein, an ultrasound probe can be provided. Inany of the embodiments disclosed herein, the release wire or releasemember 70 can have distance markings provided thereon, to assist theuser of the medical device 10 in deploying or retracting thesecomponents of the medical device 10.

With reference to FIGS. 3 and 4, in a further embodiment of the presentdisclosure, a medical device 110, similar to medical device 10 discussedabove, is provided. Medical device 110 includes a member 140, similar tomember 40 discussed above, coupled to a tube 120, similar to tube 20discussed above. The materials for the tube 120 and the member 140 aresimilar to those discussed above with reference to tube 20 and member40.

Tube 120 has a distal portion or distal end 122 and a proximal portionor proximal end 124 and defines at least one lumen 126 extendingtherebetween. A plurality of perforations or openings 128 enable fluidcommunication through an outer wall of tube 120 for the application ofsuction and/or fluid. Tube 120 further includes a closed distal end,similar to tube 20 discussed above. Tube 120 has an open proximal endconfigured to connect to a suction source and a fluid source. One ormore control members (not shown), e.g., a valve, may be disposed betweentube member 120 and the suction source to control the suction forcebeing applied. In some embodiments, controls may alternatively oradditionally be provided on a user interface (not shown) of the suctionsource. The medical device 110 has valves for each of the vacuum portand fluid/air supply port.

Continuing with reference to FIGS. 3 and 4, member 140 is formed from asemirigid, resiliently flexible material, and defines a distal portion142 having a distal end 143 and a proximal portion 144. The member 140is connected to the tube 120 through a coupling device, such as, forexample, a series of couplings 150 that can be configured as rings,sleeves, hooks, latches, etc. For example, the couplings 150 can bepieces of suture. The couplings 150 allow a gradual detachment of themember 140 from the tube 120 to help keep the stomach in a flatconfiguration. Member 140 has a U-shaped configuration, with a first leg140 a of the member 140 attached to the tube 120 by couplings 150.Couplings 150 are in the form of small suture loops inserted throughsmall slits in the leg 140 a of the member 140 and about release wire170. A second leg 140 b extends freely toward the proximal end 144. Thecouplings 150 can be breakable or otherwise releasable, or they can havea release wire 170 passed through each of the couplings 150.

The member 140 is gradually detachable by retracting the release wire170. In some embodiments, the couplings 150 can be bioabsorbable or anotherwise medically acceptable material. In the initial, contractedposition of the member 40, distal portion 142 of member 140 extendsalong and abuts the outer surface of the tube 120, and in thesubsequent, deployed position, the distal portion 142 of member 140 isbowed outwardly (see FIG. 4) from tube member 120. The member 140 isgradually deployed, as discussed above, by translating the second leg140 b with respect to the tube 120. As member 140 is moved to thedeployed position, member 140 automatically assumes the shape of thegreater curvature of the stomach by forming a bulging region 142 a and atapering region 142 b. The member 140 defines a configuration thatgenerally complements the curvature of the greater curvature of thestomach. Preferably, the flexibility and resilience and dimensioning ofthe member 140 is such that member 140 automatically assumes the shapeof the greater curvature of the stomach.

An actuator or handle 141 of proximal portion 144 of member 140 may begrasped and manipulated to position the member 140 with respect to thetube 120. Member 140 is dimensioned such that proximal portion 144 isaccessible from outside the patient.

The release wire or member 170 extends distally toward the distal end143 and is accessible at the proximal ends 124, 144 of the tube 120 andmember 140. The release wire 170 extends through each coupling 150,maintaining the connection between the member 140 and the tube 120.Translating the release wire 170 in a proximal direction gradually freesthe member 140 from the tube 120 by severing or detaching couplings 150,ensuring that the member 140 can be removed from the tube 120 before theresection and/or stapling of tissue occurs. Alternatively, couplings 150can be a frangible connection that can be broken to allow the member 140to be removed.

The procedure is performed in a manner similar to that discussed abovewith regard to medical device 10, with the member 140 being detachedfrom the tube 120 before the stapling and cutting of tissue occurs. Thesuction is maintained to stabilize the tissue and maintain tube 120 inabutment or in close proximity with the inner curvature of the stomachand the tube 120 is used as a guide for the stapler.

With reference to FIG. 11, it is contemplated that, in any of theembodiments disclosed herein, a reusable portion is provided to form asystem 2 that controls the suction and fluid/air source of any of themedical devices disclosed herein. For example, as shown in FIGS. 1 and11, system 2 includes medical device 10 and a reusable portion 11.Reusable portion 11 includes a tank T1 having a fresh supply of salineor water while a tank T2 can collect the used saline or water. A tank T3serves as a filter as the stomach volume is equalized with atmosphericpressure. There is a pressure line 13, vacuum line 15, and atmosphericline “A” leading to the medical device 10. The air pushes saline fromthe tank T1 to the stomach and its pressure can be monitored andregulated. Valve V1 and valve V2 interact with the lines 13 and 15,respectively, so that the air pressure line 13 is connected to tank T1and the air pressure pushes saline to the stomach until a predeterminedpressure is reached. Valve V1 and valve V2 are normally biased to aclosed position “B” in which both pressure and vacuum valves V1, V2 areclosed. Valves V1 and V2 are activated together.

Valves V1, V2 and a release valve V3 have three positions: “A”, “B”, and“C.” Release valve V3 is normally biased to the “A” position, whichallows the vacuum line 15 to be connected. When valve V1 and valve V2are urged to position “A” the stomach will be pressurized with fluid tocheck for leaks. When valve V1 and valve V2 are moved to position “C,”the vacuum source “S” will remove air and fluid from the stomach.Finally, moving valve V3 to the “B” position allows the internal stomachpressure to equalize with atmospheric pressure.

A safety feature is contemplated, either a mechanical or computerizedcontrol, or both, in which valve V3 is only activated if valve V1 andvalve V2 are in their closed “B” positions. In system 2, all parts usedin the patient are single patient use only, and the pre-filled tanks andvalves, etc., are reusable. These portions of the system 2 can becoupled in an appropriate manner, such as via bayonette couplings.Appropriate control buttons (see FIG. 1) can also be provided.

The medical device 10 shown in FIG. 1 can have reusable and sterilizableportions, such as, for example, a handle 51. The handle 51, with buttonsfor controlling the suction, fluid supply, valves and pressureregulation, is sterilizable and reusable, whereas the remainder of themedical device 10 is discarded after use. The medical device 10 has aport or ports for attachment to a source of saline, a used salinereservoir, and a tank at atmospheric pressure.

In another embodiment, as shown in FIGS. 5 and 6, a medical device 210,similar to medical devices 10 and 110 described above, is provided.Medical device 210 includes a tube 220, similar to tube 20 discussedabove, and a flexible member 240, similar to flexible member 40discussed above, movably, slidably or translatably coupled thereto. Tube220 has an aperture or endoscopic lumen 220 a for the passage of a scope221 through the tube 220 and into the stomach, as shown in FIG. 6. Tube220 also includes a vacuum lumen 220 b, a release wire lumen 220 c, anda leak test fluid lumen 220 d, or any combination thereof.

In another embodiment of the present disclosure, as shown in FIGS. 12and 13, a medical device 310, similar to medical device 10 discussedabove, is provided. Medical device 310 includes a member 340, similar tomember 40 discussed above, and a tube 420, similar to tube 20 discussedabove. Member 340 has a distal end 347 that is slidably connected withtube 320. Tube 320 is coupled to member 340 and deployable therefrom.Tube 320 has a distal portion 322 and a proximal portion 324 and definesat least one lumen 326 extending therethrough. Tube 320 includes aplurality of perforations or openings 328 configured to enable fluidcommunication through the outer wall of tube 320 for the application ofsuction and/or fluid. Tube 320 further includes a closed distal tip 323.

Tube 320 has an open proximal end (not shown) configured to connect to asuction source and a fluid source. One or more control members, e.g., avalve, may be disposed between tube 320 and the suction source tocontrol the suction force being applied. In some embodiments, controlsmay alternatively or additionally be provided on a user interface (notshown) of the suction source. The device 310 has valves for each of thevacuum port and fluid/air supply port.

Member 340 is formed from a semirigid, resiliently flexible material,and defines a distal portion 342 having a distal end 347 and a proximalportion 344. The member 340 is movably, translatably or slidablyconnected to the tube 320. Distal end 347 may be slidably connected to atrack of tube 320. Proximal portion 344 of member 340 may be grasped andmanipulated to position the member 340 with respect to the tube 320, andthe member 340 may have an actuator or handle (not shown) for thispurpose. As mentioned above with regard to medical device 10, member 340is dimensioned such that proximal portion 344 is accessible from outsidethe patient.

After the member 340 has been deployed in a manner similar to thatdiscussed above with regard to member 40 of medical device 10, themember 340 is gradually retracted by pulling on an actuator to retractthe distal portion 342 of the member 340 with respect to the tube 320.In the initial, contracted position of the member 340, as shown in FIG.13, distal end 347 of member 340 is disposed with a proximal portion oftube 320. In the subsequent, deployed position, as shown in FIG. 12,distal end 347 is disposed with distal end 322 of tube 320 such thatdistal portion 342 of member 340 is bowed outwardly from tube member320. The member 340 is gradually retracted by translating the distal end347 of member 340 in the proximal direction with respect to the tube320. Maintaining a deployed position, the member 340 automaticallyassumes the shape of the greater curvature of the stomach to form abulging region 342 a and a tapering region 342 b. It is contemplatedthat the member 340 can be attached to a vision device, such as, forexample, a scope 349 (see FIG. 14) that is slidably attached to the tube320.

The procedure is performed similar to that discussed above with regardto medical device 10, with the member 340 being readjusted with respectto the tube 320, as the stapling and cutting of tissue occurs. In otherwords, the distal end 347 of the member 340 is pulled in a proximaldirection, and then the tissue is stapled and cut. The distal end 347 ofmember 340 is further pulled in a proximal direction and then the tissueis again stapled and cut. The procedure proceeds in this manner untilthe desired tubular section of stomach is formed. The suction ismaintained to stabilize the tissue and maintain tube 320 in abutmentwith a smaller curvature of stomach “ST,” and the tube 320 is used as aguide for the stapler.

In a further embodiment of the present disclosure, as shown in FIGS. 15,15A, a medical device 410, similar to medical device 10 described above,is provided. Medical device 410 includes a flexible, hollow tube 420,similar to tube 20 described above, and a flexible member 440, similarto flexible member 40 described above, movably, slidably or translatablycoupled thereto. Medical device 410 further includes a balloon or otherexpandable device 480 disposed with a distal portion 422 of tube 420. Inthis way, an effective size of the medical device 410 can be adjustablyexpanded.

Balloon 480 can be provided in any of the embodiments disclosed herein,and can be used additionally or alternatively to the balloon 80discussed above. Using balloon 480, the user of the medical device 410can provided with a larger or smaller tubular section of stomach in thegastrectomy (see FIG. 15A).

In further embodiments, as shown in FIGS. 16A-16E, 17 and 18, tubes 520,620, 720, 820, 920, each similar to tube 20 described above, can beconfigured to have a cross-sectional shape that will reduce the pressureon tissue, such as, for example, stomach tissue “ST,” while stapling andcutting occurs. As shown in FIGS. 16A-16E, the cross-sectional shape canbe a solid circular core, cylindrical, oval, triangular, diamond,elliptical, etc., to reduce the pressure on the stomach tissue “ST.” Itis contemplated that any tube disclosed herein can be variously shapedin accordance with FIGS. 16A-16E.

In further embodiments, as shown in FIGS. 19A and 19B, tubes 1020, 1120,similar to tube 20 described above, is provided. It is contemplated thattubes 1020, 1120 can be a component of any medical device describedherein. Each of tubes 1020, 1120 includes openings or apertures 1028,1128, respectively, along a length thereof. Apertures 1028, 1128 canhave different density and size, distributed across tubes 1020, 1120. Itis envisioned that apertures 1028, 1128 can be distributed across anyone of tubes 20, 120, 220, 320, 420. The shape may vary according to thelocation of the openings, and can be elliptical slots, circular or othershapes.

In further embodiments, as shown in FIGS. 20A-20C, tubes 1220, 1320 and1420, similar to tube 20, are provided. Tubes 1220, 1320 and 1420 mayinclude LEDs or other lights 502 disposed within or on an outer surfacethereof. Lights 502 can be disposed on the distal ends of the tubes1220, 1320, 1420, and/or distributed across their length so that thetubes 1220, 1320, 1420 are visible through stomach tissue. It iscontemplated that one or more lights 502 can be provided on or withinany one of the tubes or other components of the medical devicesdescribed herein.

In one embodiment, as shown in FIG. 21, a tube 1520, similar to tube 20,is provided. A distal end 1522 of tube 1520 may include a vibrating tip1523 so that it is more readily located with respect to the stomachtissue during vibration thereof. It is contemplated that any one of thetubes described herein can have a vibrating tip.

It will be understood that various modifications may be made to theembodiments of the present disclosure herein. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of embodiments. Those skilled in the art will envisionother modifications within the scope and spirit of the presentdisclosure.

Certain aspects of the present disclosure are described in the followingnumbered paragraphs:

1. A medical device, comprising: a flexible hollow tube extending from aproximal end to a distal end and defining a channel therebetween, aseries of openings being defined in a distal portion of the tubeallowing for fixation of tissue using suction; a flexible member havingan initial position disposed alongside the tube and being deployable toa subsequent position in which the flexible member engages a greatercurvature of a stomach, the application of suction placing the tubealong a lesser curvature of a stomach, fixing anterior and posteriorwalls of a stomach, and preventing their movement, the tube beingvisible under stomach tissue, the flexible member being configured to bedeployable to automatically assume a shape of a greater curvature of astomach, the flexible member including a bulging region and a taperingregion when deployed, wherein the flexible member is releasably attachedto the distal end of the tube.

2. The medical device according to paragraph 1, wherein the proximal endof the tube is open.

3. The medical device according to paragraph 1, wherein the distalportion of the tube is tapered.

4. The medical device according to paragraph 1, further comprising arelease wire for separating the flexible member from the tube.

5. The medical device according to paragraph 1, wherein a distal end ofthe flexible member includes a balloon.

6. The medical device according to paragraph 5, wherein the balloon isshaped to position the flexible member in the stomach.

7. The medical device according to paragraph 1, wherein the flexiblemember includes a hinge adjacent a distal end of the flexible member.

8. The medical device according to paragraph 1, wherein the flexiblemember is selected from the group consisting of a rod and a tube.

9. The medical device according to paragraph 8, wherein the flexiblemember is made of a flexible resilient material.

10. The medical device according to paragraph 9, wherein the flexiblemember has a distal end attached to the distal end of the tube, and aproximal end manipulable from outside a patient's body.

11. The medical device according to paragraph 1, further comprising acoupling device that holds the flexible member to the tube.

12. The medical device according to paragraph 11, wherein the couplingdevice slidably attaches an intermediate portion of the flexible memberto an intermediate portion of the tube.

13. The medical device according to paragraph 1, wherein the flexiblemember is deployable to align a stomach by evening out anterior andposterior walls of a stomach and by pushing the tube and the openings inthe tube towards a lesser curvature of a stomach.

14. The medical device according to paragraph 1, wherein the proximalend of the tube is configured for connection to a suction source.

15. The medical device according to paragraph 1, wherein the tube has across-sectional shape selected from the group consisting of triangular,diamond, elliptical, and tapered.

16. The medical device according to paragraph 1, wherein at least one ofthe tube or the flexible member includes at least one illuminationdevice.

17. The device according to paragraph 1, wherein at least one of thetube or the flexible member includes a vision device.

18. A medical device, comprising: a flexible hollow tube extending froma proximal end to a distal end and defining a channel therebetween, aseries of openings being defined in a distal portion of the tubeallowing for fixation of tissue using suction; a flexible member havingan initial position disposed alongside the tube and deployable to asubsequent position in which the flexible member engages a greatercurvature of a stomach, the application of suction placing the tubealong a lesser curvature of a stomach, fixing anterior and posteriorwalls of a stomach, and preventing their movement, the tube beingvisible under stomach tissue, the flexible member being configured to bedeployable to automatically assume a shape of a greater curvature of astomach, the flexible member including a bulging region and a taperingregion when deployed, wherein the flexible member has multipleattachments to the tube, the attachments being distributed down a lengthof the tube.

19. The medical device according to paragraph 18, wherein the flexiblemember includes a distal end releasably attached to the distal end ofthe tube.

20. The medical device according to paragraph 18, further comprising arelease wire for separating the flexible member from the tube at theattachments.

21. The medical device according to paragraph 18, wherein a distal endof the flexible member includes a balloon.

22. The medical device according to paragraph 21, wherein the balloon isshaped to position the flexible member in a stomach.

23. The medical device according to paragraph 18, wherein the flexiblemember is selected from the group consisting of a rod and a tube.

24. The medical device according to paragraph 23, wherein the flexiblemember is made of a flexible resilient material.

25. The medical device according to paragraph 18, wherein the flexiblemember has a distal end attached to the distal end of the tube, and aproximal end manipulable from outside a patient's body.

26. The medical device according to paragraph 18, further comprising acoupling device that holds an intermediate portion of the flexiblemember to the tube.

27. The medical device according to paragraph 18, wherein the flexiblemember is deployable to align a stomach by evening out anterior andposterior walls of a stomach and by pushing the tube and the openings ofthe tube towards a lesser curvature of a stomach.

28. The medical device according to paragraph 18, wherein the proximalend of the tube is configured for connection to a suction source.

29. The medical device according to paragraph 18, wherein the tube has across-sectional shape selected from the group consisting of triangular,diamond, elliptical, and tapered.

30. The medical device according to paragraph 18, wherein at least oneof the tube or the flexible member includes at least one illuminationdevice.

31. The medical device according to paragraph 18, wherein at least oneof the tube or the flexible member includes a vision device.

32. A medical device, comprising: a flexible hollow tube extending froma proximal end to a distal end and defining a channel therebetween, aseries of openings being defined in a distal portion of the tubeallowing for fixation of the tube to tissue using suction; a flexiblemember having an initial position disposed alongside the tube and beingdeployable to a subsequent position in which the flexible member engagesa greater curvature of a stomach, the application of suction placing thetube along a lesser curvature of a stomach, fixing anterior andposterior walls of a stomach, and preventing their movement, the tubebeing visible under stomach tissue, the flexible member being configuredto be deployable to automatically assume a shape of a greater curvatureof a stomach, the flexible member including a bulging region and atapering region when deployed; and an expandable element disposedalongside the distal portion of the tube.

33. The medical device according to paragraph 32, wherein the expandableelement is an inflatable balloon, the balloon being inflatable toenlarge an effective diameter of the medical device.

34. The medical device according to paragraph 32, wherein the expandableelement is a lever pivotally attached to the distal end of the tube.

35. The medical device according to paragraph 34, wherein the lever canbe pivotable in two directions.

36. The medical device according to paragraph 32, wherein the proximalend of the tube is open.

37. The medical device according to claim 32, wherein the distal end ofthe tube is tapered.

38. The medical device according to paragraph 32, further comprising arelease wire for separating the flexible member from the tube.

39. The medical device according to paragraph 32, wherein the expandableelement is visible through stomach tissue.

40. The medical device according to paragraph 32, wherein the expandableelement is positioned to indicate a location for an initial staplingand/or cutting operation.

41. The medical device according to paragraph 32, wherein the flexiblemember is selected from the group consisting of a rod and a tube.

42. The medical device according to paragraph 41, wherein the flexiblemember is made of a flexible resilient material.

43. The medical device according to paragraph 32, wherein the flexiblemember has a distal end attached to the distal end of the tube, and aproximal end manipulable from outside a patient's body.

44. The medical device according to paragraph 32, further comprising acoupling device that holds the flexible member to the tube

45. The medical device according to paragraph 44, wherein the couplingdevice slidably attaches an intermediate portion of the flexible memberto an intermediate portion of the tube.

46. The medical device according to paragraph 32, wherein the flexiblemember is deployable to align a stomach by evening out anterior andposterior walls of a stomach and by pushing the tube and the openings ofthe tube towards a lesser curvature of a stomach.

47. The medical device according to paragraph 32, wherein the proximalend of the tube is configured for connection to a suction source.

48. The medical device according to paragraph 32, wherein the tube has across-sectional shape selected from the group consisting of triangular,diamond, elliptical, and tapered.

49. The medical device according to paragraph 32, wherein at least oneof the tube or the flexible member has at least one illumination device.

50. The medical device according to paragraph 32, wherein at least oneof the tube or the flexible member has a vision device.

51. A medical device, comprising: a flexible hollow tube extending froma proximal end to a distal end and defining a channel therebetween, atleast one opening being defined in a distal portion of the tube; aflexible member having an initial position disposed alongside the tubeand being deployable to a subsequent position, the flexible member beingconfigured to be deployable to automatically assume a shape of a greatercurvature of a stomach; and a reusable portion having a first tankincluding a fluid, a second tank for receiving material, and a thirdtank communicating with atmospheric pressure, the reusable portionhaving a first valve, a second valve, and a third valve, the first valveand the second valve each having a first position, a second position,and a third position, the channel being delivered with pressurized fluidwhen the first valve and the second valve are moved to the firstposition.

52. The medical device according to paragraph 51, wherein the secondposition of the first valve and the second valve is a closed position.

53. The medical device according to paragraph 51, wherein the thirdvalve has a position in which a vacuum is provided to the channel.

54. The device according to paragraph 51, further comprising a safetyfeature preventing the third valve from moving to an open positionunless the first valve and the second valve are moved to the secondposition and wherein the second position of the first valve and thesecond valve is a closed position.

1-20. (canceled)
 21. A medical device, comprising: a flexible hollowtube extending from a proximal end to a distal end and defining achannel therebetween, a series of openings being defined in a distalportion of the tube allowing for fixation of tissue using suction, theapplication of suction placing the tube along a lesser curvature of astomach, fixing anterior and posterior walls of the stomach, andpreventing their movement, the tube being visible under stomach tissue;a plurality of illumination devices distributed along a length of thetube; and a vision device coupled to the tube.
 22. The medical deviceaccording to claim 21, wherein the vision device is selected from thegroup consisting of a camera and a scope.
 23. The medical deviceaccording to claim 21, wherein the vision device is slidably attached tothe tube.
 24. The medical device according to claim 21, wherein theplurality of illumination devices are LEDs.
 25. The medical deviceaccording to claim 21, wherein the plurality of illumination devices aredisposed within or on an outer surface of the tube.
 26. The medicaldevice according to claim 21, wherein the proximal end of the tube isopen.
 27. The medical device according to claim 21, wherein the distalend of the tube is tapered.
 28. The medical device according to claim21, wherein the proximal end of the tube is manipulable from outside apatient's body.
 29. The medical device according to claim 21, whereinthe proximal end of the tube is configured for connection to a suctionsource.
 30. The medical device according to claim 21, further comprisinga flexible member having a distal end slidably connected to the tubesuch that the distal end of the flexible member is configured to slidedistally relative to and along the length of the tube from an initialposition in which the distal end of the flexible member is coupled tothe proximal end of the tube to a deployed position in which the distalend of the flexible member is coupled to the distal end of the tube andbows outwardly from the tube.
 31. The medical device according to claim30, wherein the flexible member is configured to be deployable toautomatically assume a shape of a greater curvature of the stomach. 32.The medical device according to claim 31, wherein the flexible memberincludes a bulging region and a tapering region when deployed.
 33. Themedical device according to claim 30, wherein the flexible member isselected from the group consisting of a rod and a tube.
 34. The medicaldevice according to claim 30, further comprising a coupling device thatholds the flexible member to the tube.